The present invention relates generally to a surgical fastener, and more particularly to a surgical fastener having sheet metal components.
Gastroesophageal reflux disease or persistent heartburn is caused by an improper relaxation of the lower esophageal sphincter, allowing acidic stomach contents to travel into the esophagus. If left untreated, chronic reflux may cause esophageal stricture, bleeding ulcers, perforation, and scarring. Continued reflux may lead to Barrett's esophagus, involving changes in the esophageal cells and possibly leading to cancer. Antacids and proton pump inhibitors are initially used to treat this condition. If these treatments are unsuccessful, surgical intervention is often recommended.
One interventional surgical method is known as Nissen fundoplication. This procedure involves wrapping a fundus of the stomach around the lower end of the esophagus and fastening it in place to make the lower esophageal sphincter less compliant. Traditionally, this procedure was accomplished by open surgery using sutures to secure the plicated fundus of the stomach around the esophagus without penetrating the stomach. More recently, laparoscopic Nissen procedures have been used. In some laparoscopic procedures, surgical fasteners are used with an endoscopic applicator. Several different fastener designs have been developed. Some of these designs include a two piece fastener. A first of these pieces includes a base having two straight elongate needles extending perpendicularly outward from the base generally parallel to each other. A second piece includes a receiver element having openings positioned for receiving the needles of the first piece and a lock for holding the needles in place once received in the openings. In use, tissue is gathered, the needles of the first piece are pushed through the gathered tissue and the openings of the second piece to hold the tissue and fastener in place. U.S. Pat. No. 7,033,378, entitled “Surgical Fastener, Particularly for the Endoluminal Treatment of Gastroesophageal Reflux Disease (GERD)” and issued on Apr. 25, 2006, which is hereby incorporated by reference, discloses one such fastener and an applicator used with this fastener.
Although prior examples of tissue fasteners work well for their intended purpose, they can be improved by reducing their cost. Current designs require molding some components and a complex assembly process. There is a need for a fastener made by less expensive processes.